CARPL

GUDID 00086001291630

Carpl.AI, Inc.

Radiology DICOM image processing application software

• Primary Device ID: 00086001291630
• NIH Device Record Key: a44c7dd0-b474-40e8-8d67-cf93f88d8d77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARPL
• Version Model Number: V2
• Company DUNS: 119393209
• Company Name: Carpl.AI, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00086001291630 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232891

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-15
• Device Publish Date: 2026-01-07